AsthmaNCT01286532
Asthma in Children
An observational study of Asthma, run by AstraZeneca at 11 sites in Russia.
Trial summary
This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- How many people
- 283 participants
- Where
- 11 sitesRussia
- Study dates
- Apr 2011to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS and LABA who have completed at least one valid CACT assessment after the study entry
Who may be able to join
- Child (male or female) aged 5 to 11 years inclusive
- Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)
- The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment
- The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for > 3 consecutive days)
- Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms
- The patient administered with short-acting β2 agonists (inhalational) or rapidly released methylxanthines (oral) in the doses approved for the respective age as a rescue on-demand therapies during the preceding month
Who cannot join
- Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development
- Severe comorbidities affecting the patient's overall performance
- In the physician's opinion, the patient is not able to comply with the protocol requirements
- Expected specific hyposensibilization within next 6 months
- Expected treatment at health resort facilities within next 6 months
- Other reasons that in the physician's opinion will prevent reliable assessments of the study treatment efficacy
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Research site
Chelyabinsk
Research site
Moscow
Research site
N.Novgorod
Research site
Novosibirsk
Research site
Rostov-on-Don
Research site
Saint Petersburg
Research site
Samara
Research site
Tula
Research site
Tver'
Research site
Ufa
Research site
Volgograd
About this study
Official title: A Six-month Non-interventional Prospective Study of Various Controller Therapies for Moderate Persistent and Severe Persistent Asthma in Children in Real Life Outpatient Clinical Practice
This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.
- Conditions
- Asthma
- Keywords
- Asthma, Asthma in Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS(inhalation glucocorticosteroids) and LABA ( long-acting b2-agonist) who have completed at least one valid CACT assessment after the study entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19)
Measured: 3 visits for 6 month
Secondary outcomes (4)
To determine mean number of severe bronchial asthma exacerbations within 6 months
Measured: 3 visits for 6 month
To determine mean duration of bronchial asthma exacerbations including hospital admissions, daytime hospital treatment and any cases of oral administration of glucocorticoids > 3 consecutive days during the observation period
Measured: 3 visits for 6 month
To determine mean requirement in short-acting β2-agonists and/or rapidly released methylxanthines per week during the period of observation
Measured: 3 visits for 6 month
To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)
Measured: 3 visits for 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286532
- Sponsor's protocol ID
- NIS-RRU-XXX-2010/1
- Status last verified
- Jan 2013
- First submitted
- 28 Jan 2011
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month Non-interventional Prospective Study of Various Controller Therapies for Moderate Persistent and Severe Persistent Asthma in Children in Real Life Outpatient Clinical Practice
- ClinicalTrials.gov ID
- NCT01286532
- Acronym / sponsor ID
- NIS-RRU-XXX-2010/1
- Conditions
- Asthma
- Keywords
- Asthma, Asthma in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS(inhalation glucocorticosteroids) and LABA ( long-acting b2-agonist) who have completed at least one valid CACT assessment after the study entry |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children (male or female) aged 5 to 11 years inclusive on step 3 asthma combination therapy with ICS and LABA who have completed at least one valid CACT assessment after the study entry
Key inclusion criteria (6 listed)
- Child (male or female) aged 5 to 11 years inclusive
- Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)
- The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment
- The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for > 3 consecutive days)
- Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms
Key exclusion criteria (6 listed)
- Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development
- Severe comorbidities affecting the patient's overall performance
- In the physician's opinion, the patient is not able to comply with the protocol requirements
- Expected specific hyposensibilization within next 6 months
- Expected treatment at health resort facilities within next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19)
Time frame: 3 visits for 6 month
4 secondary outcomes
To determine mean number of severe bronchial asthma exacerbations within 6 months
Time frame: 3 visits for 6 month
To determine mean duration of bronchial asthma exacerbations including hospital admissions, daytime hospital treatment and any cases of oral administration of glucocorticoids > 3 consecutive days during the observation period
Time frame: 3 visits for 6 month
To determine mean requirement in short-acting β2-agonists and/or rapidly released methylxanthines per week during the period of observation
Time frame: 3 visits for 6 month
To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)
Time frame: 3 visits for 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19) (time frame: 3 visits for 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.